With the exception of Forest Labs, small companies haven't been able to build sustainable businesses in primary care because they can't generate enough returns (generally from expensive-to-acquire marketable products) to both restock a pipeline and drop requisite profits to the bottom line. Now Sepracor aims to be the first to do so, thanks to a research shortcut. Investors, hungry for a successful biopharma business model, are watching closely.

The company cited lackluster efficacy in its decision to discontinue development of V590 and V591. It will instead develop two drugs to treat COVID-19.

The regulatory tools are for use in medical device development.